Nephron Recalls Fentanyl and Bupivacaine Injection Due to Glass Contamination
Nephron Pharmaceuticals is recalling 1,855 bags of Fentanyl Citrate and Bupivacaine HCl injection due to potential glass contamination.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves potential glass contamination in an injectable medication, which poses a significant risk of injury.
Plain-English summary
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center is recalling 1,855 bags of PF-Fentanyl Citrate (2 mcg/mL) & Bupivacaine HCl 0.0625% in 0.9% Sodium Chloride Injection. The recall is being conducted due to Good Manufacturing Practice (GMP) deviations that resulted in potential glass contamination.
The affected product is distributed nationwide. The specific lots involved are FB9001 A (Exp. 10/31/2019), FB9001B (Exp. 10/31/2019), FB9013A (Exp. 12/08/2019), and FB9015A (Exp. 12/14/2019). The product is identified by NDC 69374-0525-25.
Healthcare providers and patients should stop using the affected product and contact the manufacturer or their local FDA office for further instructions.
The recalled product
- Product
- PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,855
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lots: FB9001 A Exp. 10/31/2019
- FB9001B Exp. 10/31/2019
- FB9013A Exp. 12/08/2019
- FB9015A Exp. 12/14/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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